Kornimate/medical-research-clean huggingface dataset:
safety study of radiation and cp-675,206 infusion for breast cancer patients

Conditions: Metastatic Breast Cancer

Summary: the purpose of this study is to determine the maximum dose of cp-675,206 when given in combination with radiation. patients will be given local radiation to one tumor site and an intravenous infusion of cp-675,206.

breast cancer is the most common cancer in canadian women. in 2007 an estimated 22,300 women will be diagnosed and 5300 will die of the disease. despite advances in therapy, metastatic disease remains an incurable illness, with a median survival of only 2 years. standard systemic treatment options for metastatic disease include chemotherapy or hormonal therapy. radiation is frequently used in the metastatic setting for palliation of symptoms, with the most frequent site of radiation being bone. response rates to first line chemotherapy are in the range of 30%, however these responses are not durable. currently there are no curative options for metastatic disease, underscoring the need for novel therapeutic approaches. ctla4 is a receptor expressed on the surface of activated t cells and regulatory t cells. ctla-blockade has been tested in clinical trials using humanized monoclonal antibodies, and some biological responses have been reported. the anti-tumor immune response may be further augmented by the combination of ctla4-blockade with radiation, with the potential to mediate regression of metastases outside of the field of radiation. the primary goal of this study therefore is to establish the safety of ctla4-blockade using the antibody cp-675, 206 in combination with radiation. this trial is being conducted as a prelude to a planned phase ii trial of cp-675,206 in combination with radiation in metastatic breast cancer.

Eligibility criteria:
inclusion criteria: * inoperable locally recurrent or metastatic breast cancer * performance status 0-1 * adequate organ function as determined by lab tests * greater than 3 weeks since any chemotherapy treatment * greater than 2 weeks since last dose of hormonal therapy exclusion criteria: * previous treatment with any anti-ctla4 agent * patients with active diarrhea * patients who will receive radiation to pelvic lesions * history of chronic inflammatory or autoimmune disorder * history of insulin-dependent diabetes * history in the last 5 years of any chronic gastrointestinal conditions * history within the last year of congestive heart failure, stroke, myocardial infarction or thromboembolic event * patients with known brain metastasis * concurrent treatment with immunosuppressive medication for longer than 10 days within 4 weeks of enrollment or while on trial * patients of reproductive potential not using effective contraception, breast-feeding, or patients who test positive for pregnancy at enrollment
effect of probiotics consumed during pregnancy on the incidence of mastitis

Conditions: Mastitis; Breast Milk; Lactation; Women's Health; Infant Health

Summary: the aim of the present study is to evaluate the effect of consumption during pregnancy and the lactation period of the probiotic l. fermentum cect5716 on the incidence of mastitis. bacterial load and immunological parameters in breast milk, parameters related to breastfeeding as well as health parameters of the mother and baby will also be evaluated.

pregnancy and lactation are important moments for the child that will determine their development and future health. one of the key processes is when the microbiota is established in the baby. contamination during delivery with the mother's vaginal flora, as well as bacteria from the microbiota of breast milk, are important sources for intestinal colonization. however, the mother's microbiota can suffer alterations that affect the health of the mother and can also have an effect on the baby. mastitis is a condition of the mammary gland that can affect between 3-30% of women during the period of lactation and is the first cause of abandonment of it. it is associated with a dysbiosis with the proliferation of microorganisms in milk such as staphylococcus and streptococcus. previous studies carried out with the strain l. fermentum cect5716 have demonstrated a powerful regulating activity of the microbiota of breast milk that translates into a preventive and curative effect on mastitis. the highest incidence of mastitis occurs during the first weeks after delivery, so the investigator's working hypothesis is that the modulation of the maternal microbiota before delivery would improve the effectiveness of the probiotic strain consumption.

Eligibility criteria:
inclusion criteria: * normal development of pregnancy * single fetus pregnancy * be in week 28-32 of pregnancy * intention to breastfeed the child for 16 weeks exclusion criteria: * having a breast disease that hinders or prevents breastfeeding * have been taking probiotic supplements 2 weeks before starting the study * have a low expectation of adherence to the study protocol

Keywords: probiotics gestation lactation mastitis
ugt1a1 combined with pharmacokinetics of sn-38 in cpt-11-based crt in patients with advanced rectal cancer

Conditions: Locally Advanced Rectal Cancer

Summary: the study evaluates the associations between peak and valley concentrations of sn-38 with the efficacy and adverse effects of advanced rectal cancer patients carrying genotype (ta) 6 /(ta) 6 or (ta) 6 /(ta) 7 after neoadjuvant chemoradiotherapy with cpt-11.all participants will be scheduled to receive surgery 6-8 weeks after the completion of crt. the primary end point are toxicity and pcr rate.


Eligibility criteria:
inclusion criteria: * pathological confirmed adenocarcinoma * clinical stage t3-4 and/or n+ * the distance from anal verge less than 12 cm * without distance metastases * performance status score: 0\~1 * ugt1a1\*28 6/6 or 6/7 * without previous anti-cancer therapy * sign the inform consent exclusion criteria: * pregnancy or breast-feeding women * serious medical illness * baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/l, hb≥90g/l, plt≥100×10\^9/l, alt/ast ≤2.5 uln, cr≤ 1 uln * dpd deficiency * ugt1a1\*28 7/7

Keywords: neoadjuvant chemoradiotherapy irinotecan sn-38
study to understand novel biomarkers in researching dementia

Conditions: Alzheimer Disease; Mild Cognitive Impairment; Dementia

Summary: the purpose of this study is to determine the relationships between amyloid, tau, and neurodegeneration biomarkers in the blood and the presence of alzheimer's disease (ad) pathology, clinical cognitive decline, and diagnosis. we aim to understand how well blood-based biomarkers can diagnose and predict alzheimer's disease, which will help to further develop and validate blood tests for the disease.

all participants who are eligible and provide informed consent will complete an initial study visit, which includes a research blood collection and cognitive assessments. depending on the results of the cognitive assessments, participants will complete follow-up visits annually or biennially for additional cognitive testing, research blood collections, and potential clinical testing for alzheimer's disease as determined by the participant's medical provider.

Eligibility criteria:
inclusion criteria: * at least 60 years of age * 80% of the newly enrolled clinic-based cohort will have symptoms of forgetfulness, mild cognitive impairment, mild dementia, or alzheimer's disease as determined by their medical chart and/or provider * all seabird participants will be invited to participate regardless of their cognitive status exclusion criteria: * unable to perform one or more basic activities of daily living (eating, bathing, dressing, ambulating, toileting) due to cognitive impairment * uncontrolled hepatitis b, hepatitis c, or hiv at time of blood collection * taking a disease-modifying drug for ad at time of enrollment * blood transfusion in the last three months * unwilling or unable to participate in all study activities
drug-drug interaction study between telaprevir and buprenorphine

Conditions: Hepatitis C; Opioid-Related Disorders

Summary: the purpose of this study is to investigate the drug-drug interaction potential between telaprevir and buprenorphine/naloxone. an understanding of the interaction potential will help to determine whether buprenorphine dose adjustments are necessary for patients who are concomitantly treated with telaprevir. telaprevir, in combination with other antiviral agents, is being investigated for the treatment of chronic hepatitis c virus infection. buprenorphine/naloxone is used for maintainance therapy in patients with opioid dependence.


Eligibility criteria:
inclusion criteria: * males or females between the ages of 18 and 64 years, inclusive. females must be of non-childbearing potential. * receiving once daily buprenorphine/naloxone maintenance therapy at a stable dose not exceeding 24 mg/6 mg, respectively, for at least 2 weeks prior to screening. exclusion criteria: * illicit use of drugs such as cocaine, amphetamines and methylenedioxymethamphetamine (mdma), barbiturates, benzodiazepines, tricyclic antidepressants, methadone or opiates/opioids (apart from buprenorphine). * treatment with any investigational drug within the last 30 days, or 5 half-lives, whichever is longer. * blood donation of 500 ml or more within the last 56 days. * infected with hepatitis b virus, hepatitis c virus, or human immunodeficiency virus (hiv).
the effect of cpap on lung hyperinflation in patients with osa

Conditions: Obstructive Sleep Apnea

Summary: assessment of the lung hyperinflation by bodypletysmography in patients with obstructive sleep apnoea treated with continuous positive airway pressure therapy.

rationale: obstructive sleep apnoea (osa) is characterized by repetitive closure of upper airways leading to apnoea (complete airflow cessation) or hypopnoea (airflow limitation \> 50% + blood oxygen desaturation \> 3% or airflow limitation \> 30% blood oxygen desaturation \> 4%). the prevalence of lung hyperinflations in sleep apnoea patients and effect of continuous positive airway pressure (cpap) therapy is not known. process: subjects included in the study will be obstructive sleep apnoea (osa) patients diagnosed by respiratory polysomnography performed in the sleep laboratory, department of respiratory medicine, university hospital olomouc. bodypletysmography will be performed in the time of osa diagnosis and after 3 months of cpap therapy. data will be statistically evaluated after completion of the target number of subjects.

Eligibility criteria:
inclusion criteria: * obstructive sleep apnoea syndrome indicated for cpap therapy (apnoea- hypopnoea index ˃ 15) exclusion criteria: * - bilevel positive airway pressure therapy * total lung capacity \< 80% lower limit of normal values * obstructive ventilatory disorder * change in body weight ˃ 10% * change in smoking status

Keywords: obstructive sleep apnea continuous positive airway pressure lung hyperinflation
a disease management study targeted to reduce health care utilization for patients with congestive heart failure

Conditions: The Focus is to Investigate Effects of a Disease Management Intervention for Patients With Congestive Heart Failure

Summary: the aim of this study is to determine whether a nurse-managed telephone-based disease-management intervention can reduce healthcare utilization and improve self-assessed health status in patients with congestive heart failure.


Eligibility criteria:
inclusion criteria: * patients with ≥1 unplanned inpatient occasion with primary diagnosis of heart failure ( i50) during the last 12 months * heart failure grade nyha ii- iii * accurate heart failure diagnosis * living in one of four swedish counties where the trial is ongoing exclusion criteria: * deceased * in a moribund state * significant cognitive loss and therefore cannot provide consent * psychosis diagnosis * severe hearing impairment * language difficulties * participants in another study
postoperative crp levels and vaginal cuff hematoma

Conditions: Postoperative Hematoma

Summary: after laparoscopic hysterectomy, authors aimed to determine cuff hematoma and a postoperative crp value to help predict the other complications. a total of 136 patients who underwent total laparoscopic hysterectomy (tlh) were evaluated. crp, white blood cell (wbc) and hemoglobin values (hb) were measured on the 1st, 2nd and 7th days before and after the operation. complications, pre-postoperative vaginal length and female sexual function were evaluated. fourteen patients who developed cuff hematoma during postoperative follow-up were analyzed with the receiver operating characteristics (roc) curve. roc curves with the largest area under the curve for each inflammatory marker were compared in order to define the marker with higher diagnostic accuracy.


Eligibility criteria:
inclusion criteria:women who underwent tlh operation with benign gynecological indications exclusion criteria: * decided to switch to laparotomy during operation * postoperative complication due to relaparotomy * infection (including urinary system and lung infections) * blood transfusion after tlh * with rheumatic diseases * length of hospital stay due to wound infection

Keywords: cuff hematoma crp levels
smoking: a risk factor for pulmonary arterial hypertension?

Conditions: Pulmonary Hypertension

Summary: environmental factors may play a role in the genesis of pulmonary hypertension, especially in endothelial dysfunction. one widespread environmental factor associated with systemic endothelial dysfunction is cigarette smoke. it may well be that cigarette smoking is not only a risk factor for systemic but also for pulmonary vascular diseases and herewith may interact with other risk factors such as a genetic background and associated conditions. the existing studies which deal with this subject are only small single center case control studies providing less data. therefore a large european multicenter study is necessary. the investigators hypothesis are: * a history of tobacco smoke exposure is highly prevalent in patients with pah compared to the unaffected general population. * a history of tobacco smoke exposure is more prevalent in patients with pah compared to cteph.


Eligibility criteria:
inclusion criteria: * pulmonary artery pressure \>25mmhg * pulmonary capillary occlusion pressure ≤15mmhg exclusion criteria: * pulmonary artery pressure \<25mmhg * pulmonary capillary occlusion pressure \>15mmhg

Keywords: pulmonary arterial hypertension chronic thromboembolic pulmonary hypertension smoking
virtual dignity therapy for palliative care patients with advanced cancer

Conditions: Advanced Cancer

Summary: the purpose of this study is to determine if it is feasible and acceptable to recruit for and deliver the virtual dignity therapy intervention to palliative care patients with advanced cancer.

this study is an investigator-initiated, single site mayo clinic rochester prospective minimal risk pilot study to determine feasibility and acceptability of virtual dignity therapy. the dignity therapy intervention is a brief, individualized psychotherapy that aims to relieve psycho-emotional and existential distress and improve the experiences of patients whose lives are impacted by serious illness. this therapy offers patients an opportunity to reflect on their life with a trained facilitator and share their thoughts and memories with family and other people in their life. this therapy consists of a total of 3 sessions, with each session 2-4 weeks apart, in which the investigator provides questions focused on life review. the sessions are recorded and transcribed. the interventionist will work with patients to edit the document and provide a final generativity document for patient to keep and give to loved ones.

Eligibility criteria:
inclusion criteria: * age ≥18 years * english fluency * no diagnosed dementia * diagnosis of advanced cancer * expected prognosis \> 6 months * provide informed consent * ability to complete questionnaire(s) by themselves or with assistance exclusion criteria: * other psychological co-morbidities such as untreated schizophrenia, bipolar disease * recent suicide attempt or psychiatric illness severe enough that hospitalization has been necessary in last 6 months * active delirium * participation in concurrent legacy offerings through the palliative care clinic inclusion criteria for caregivers: * age ≥18 years * english fluency * provide informed consent * supported patient through dignity therapy

Keywords: dignity therapy
a study of byl719 in adult patients with advanced solid malignancies, whose tumors have an alteration of the pik3ca gene

Conditions: Advanced Solid Tumors With an Alteration of the PIK3CA Gene; Estrogen Receptor Positive Breast Cancer

Summary: this is a first-in-man trial, in which byl719 will be administered to adult patients with advanced solid tumors, whose tumors have an alteration of the pik3ca gene and whose disease has progressed despite standard therapy or for whom no standard therapy exists. a combination of byl719 with fulvestrant will also be investigated in post-menopausal patients with locally advanced or metastatic breast cancer whose tumors have an alteration of the pik3ca gene. the single agent mtd dose expansion cohort and the fulvestrant combination mtd dose expansion cohort will also include er+/her2- breast cancer patients whose tumors have the wild type pik3ca gene


Eligibility criteria:
inclusion criteria: * patients with histologically-confirmed, advanced unresectable solid tumors who have progressed within three months before screening/baseline visit only patients who have confirmed pik3ca status (wild type, mutation or amplification) will be allowed for screening (patients participating in the combination arm must be eligible for treatment with fulvestrant) * availability of a representative formalin fixed paraffin embedded tumor tissue sample * at least one measurable or non-measurable lesion * age ≥ 18 years * world health organization (who) performance status ≤ 2 * good organ (hepatic, kidney, bm) function at screening/baseline visit exclusion criteria: * brain metastasis unless treated and free of signs/symptoms attributable to brain metastasis in the absence of corticosteroid therapy (anti-epileptic therapy is allowed). * prior treatment with pi3k, akt or mtor inhibitor and failure to benefit * patient with peripheral neuropathy nci-ctc grade ≥ 3 * patient with diarrhea nci-ctc grade ≥ 2 * patient with acute or chronic pancreatitis * impaired cardiac function or clinically significant cardiac disease incl. unstable angina pectoris ≤ 3 months prior to starting study drug and acute myocardial infarction (ami) ≤ 3 months prior to starting study drug. * patients with clinically manifest diabetes mellitus, history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus * women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control other protocol-defined inclusion/exclusion criteria may apply

Keywords: advanced solid tumors mutation amplification wild type pik3ca gene dose-escalation estrogen receptor positive breast cancer
assessment of vascular endothelial function in postural tachycardia syndrome

Conditions: Postural Tachycardia Syndrome

Summary: the purpose of this study is to see if people with postural tachycardia syndrome (pots) have different levels of certain chemicals in their blood than people who don't have pots. this study will test whether the blood vessels of people with pots will react differently to certain tests than people without pots. the hypothesis of the study is: patients with pots will have vascular endothelial dysfunction compared with control subjects.


Eligibility criteria:
inclusion criteria: all: * ages between 18-60 years old * male and female subjects are eligible * able and willing to give informed consent additional criteria for pots: * diagnosed with postural tachycardia syndrome by the vanderbilt autonomic - dysfunction center (1. increase in heart rate \>/= 30 beats/minute with position change from supine to standing for 10 minutes and/or 2. chronic symptoms consistent with pots that are worse when upright and get better with recumbence. additional criteria for control subjects: * healthy, non-obese, non-smokers without orthostatic tachycardia * selected to match profiles of pots patients (gender, age) * not using vasoactive medications exclusion criteria: * overt cause for postural tachycardia (such as acute dehydration) * inability to give, or withdraw informed consent * pregnancy * other factors in the investigator's opinion would prevent the subject from completing the study

Keywords: pots vascular endothelial function
evaluating length and depth estimation accuracy of laypersons and health-care providers

Conditions: Cardiopulmonary Resuscitation

Summary: the objective of the study is to measure accurateness of length and depth estimation of laypersons and health-care providers.

the study hypothesis is that both laypersons and health-care providers will have difficulty estimating length and depth. the study will enroll 100 laypersons and 100 health-care providers. the participants will be asked to draw a 5cm line without assistance an estimate 5cm depth to measure accurateness of length and depth estimation.

Eligibility criteria:
inclusion criteria: * laypersons: adult laypersons without cardiopulmonary resuscitation training within 2 years * health-care providers: adult health-care providers (doctors, nurses and emergency medical technicians) exclusion criteria: * laypersons: laypersons with cardiopulmonary resuscitation training within 2 years. * health-care providers: health-care providers who are inactive (not currently working at medical facilities)

Keywords: cardiopulmonary resuscitation cardiac arrest